IV Start Kit Custom SMP # A-Z

Q: What is the product code of K922533?

The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.

FDA 510(k) K922533 · Specialty Medical Products Co.

Unknown

510(k) numberK922533

Submission

Device name: IV Start Kit Custom SMP # A-Z
Applicant: Specialty Medical Products Co.
Little Rock, AK, US
Received: May 28, 1992
Decision date: March 23, 1993
Decision: Unknown (SEKD)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: LRS – I.V. Start Kit
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5200
Specialty: General Hospital

This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification…

Other 510(k)s with product code LRS

510(k)	Device	Applicant	Decision
K050654	Amsino I.V. Start KitLRS · Traditional	Amsino International, Inc.	05/02/2005SE
K001879	Infusion IV SetLRS · Traditional	Nirvi Intl. USA	11/20/2001SE
K963722	IV Start KitLRS · Traditional	Grand Medical Products	11/27/1996SE
K951167	EMS I.V. Start KitLRS · Traditional	Emergency Medical Supply, Inc.	05/16/1995SN
K950184	B. Braun IV Start KitsLRS · Traditional	B. Braun of America, Inc.	03/15/1995SEKD
K944041	Personal Hearing SystemLRS · Traditional	Resound Corp.	12/27/1994SE
K943941	Safestart Vascular Access Start KitLRS · Traditional	Becton Dickinson Vascular Access, Inc.	10/20/1994SE
K935684	IV Start KitLRS · Traditional	Cush Medical Products	06/10/1994SEKD
K942238	I.V. Startpak Vascular Access Start KitLRS · Traditional	Bd Becton Dickinson Vacutainer Systems Preanalytic	06/03/1994SE
K941469	IV Start KitLRS · Traditional	Clinical Resources, Inc.	05/12/1994SE

More from Clinical Resources, Inc.

510(k)	Device	Decision
K924707	Various Anesthetic Kits or TraysCAZ · Traditional	06/17/1993SEKD
K922845	Basic Dressing Change Tray SMP 102AFRG · Traditional	12/29/1992SEKD
K874596	Perforated Soaking TubeGBQ · Traditional	12/02/1987SE

Questions and answers

When was IV Start Kit Custom SMP # A-Z cleared by the FDA?

IV Start Kit Custom SMP # A-Z (K922533) received a 510(k) decision of Unknown on March 23, 1993, 299 days after the submission was received.

What is the product code of K922533?

The FDA product code is LRS – I.V. Start Kit, a Class II (moderate risk) device regulated under 21 CFR 880.5200.